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Extracellular Vesicles and Particles (EVP) as Biomarkers of Recurrence in Non-Small Cell Lung Cancer

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05424029
Collaborator
(none)
200
Enrollment
1
Location
23.6
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to find out if fluid rinsed from peoples' airways (bronchial washing samples) during routine surgery to remove (resect) their non-small cell lung cancer (NSCLC) tumors contains enough vesicles to do testing that may help the researchers learn more about their NSCLC.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Extracellular Vesicles and Particles (EVP) as Biomarkers of Recurrence in Non-Small Cell Lung Cancer
    Actual Study Start Date :
    Jun 14, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. to isolate exosomes from bronchial washings [day 1]

      every patient from whom the essential specimens have been acquired will be evaluated to determine if more than 100,000 microvesicles can be isolated for exosome purification

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All patients ≥ 18 years of age undergoing consideration of surgical resection, including lobar resections, sublobar resections, and pneumonectomies, for primary lung cancer will be eligible.

    • Patients with previously resected disease and/or previous radiation therapy will be considered on a case by case basis.

    Exclusion Criteria:

    • Patients with active infection or pneumonia which may impact exosome makeup

    • Additionally, if at the discretion of the operating surgeon, obtaining bronchial washings would lead to undue morbidity, the patient would be excluded and replaced

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center

    Investigators

    • Principal Investigator: David Jones, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05424029
    Other Study ID Numbers:
    • 22-155
    First Posted:
    Jun 21, 2022
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Memorial Sloan Kettering Cancer Center
    Extracellular Vesicles and Particles
    Biomarkers
    22-155
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Recurrence

    Study Results

    No Results Posted as of Jun 21, 2022